Infant Carrier for Postpartum Health

Overseen By R. Aver Yakubu, MHA, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nurturely

Disqualifiers: Under 18, Multiple births, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether using baby carriers (also known as infant carriers or baby slings) can improve postpartum health outcomes, such as increasing breastfeeding rates and reducing postpartum depression, particularly for Black birthing parents. The trial will test if carrying babies close can support mental health and mother-infant bonding while respecting cultural practices. Participants will either start using a carrier shortly before birth or wait six months, learning safe usage through a video and home visits. Those who are currently pregnant with one baby, can use a smartphone, and are part of specific community programs might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to understanding cultural practices in postpartum care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this infant carrier is safe for postpartum health?

Research has shown that infant carriers are generally safe when used according to safety guidelines. These guidelines emphasize the correct positioning of the baby to prevent injury. For example, the US Consumer Product Safety Commission (CPSC) has established safety standards to ensure the security of infant sling carriers. These standards help reduce risks like suffocation or falls due to improper positioning.

A previous study on soft infant carriers found positive outcomes, such as increased breastfeeding and reduced postpartum depression, with no major safety issues reported. It is crucial to ensure the baby's face remains visible and their chin is not pressed against their chest, as this can obstruct breathing.

In summary, while infant carriers are designed for safety, correct usage is essential. Following the provided safety instructions and ensuring a proper fit can help prevent potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Infant Carrier for postpartum health because it offers a unique, hands-on approach that integrates ergonomic support with parental education, unlike traditional postpartum care that typically focuses on medical check-ups and advice. This intervention emphasizes practical training, where parents learn to use the carrier safely and effectively through demonstration and practice, empowering them with skills for everyday use. By enhancing parent-infant bonding and potentially improving physical health through ergonomic use, this method could provide holistic benefits that standard postpartum care does not typically address.

What evidence suggests that using an infant carrier is effective for improving postpartum health?

Research shows that using a baby carrier can benefit new mothers' health after childbirth. In this trial, participants in the intervention group will receive an ergonomic baby carrier and training on its use. One study found that providing mothers with an ergonomic baby carrier reduced signs of postpartum depression. Another study found that using a baby carrier can help mothers breastfeed more successfully. Additionally, research indicates that carrying a baby in a carrier can strengthen the bond between mother and baby and help calm the infant. These findings suggest that baby carriers might be a useful tool for improving mental health and breastfeeding success after childbirth. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for Black birthing parents who are over 18, currently pregnant with one baby, fluent in a study language, have internet access via smartphone, an email account, and can physically and mentally use an infant carrier. They must be part of a participating agency.

Inclusion Criteria

Currently pregnant with a singleton pregnancy

I can physically and mentally manage an infant carrier, follow the study's instructions, and keep records of my participation.

Current participant of one of the participating agencies

Exclusion Criteria

Cannot use an infant carrier

No working email

Not a current participant of a partner agency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Training

Participants in the intervention group receive training on using the infant carrier around 37 weeks gestation

1 week

1 visit (in-person)

Postpartum Intervention

Participants use the infant carrier to increase physical contact with infants, supported by home visitation

24 weeks

Regular home visits

Follow-up

Participants are monitored for lactation and postpartum depression outcomes

52 weeks

Follow-up assessments at weeks 6, 12, 24, and 52

What Are the Treatments Tested in This Trial?

Interventions

• Infant Carrier

Trial Overview

The trial tests whether using soft infant carriers increases lactation rates and decreases postpartum depression among Black birthing parents. It's based on previous successful trials in Latinx communities and integrates culturally specific care within perinatal home visiting programs.

How Is the Trial Designed?

Group I: Infant Carrier Experimental Treatment 1 Intervention

In the intervention group, in the prenatal period (\~37 weeks gestation) will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Group II: Infant Carrier Waitlist Active Control 1 Intervention

Participants assigned to the waitlist control will receive home visitation care as usual. At 6-months postpartum they will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

Who Is Running the Clinical Trial?

Nurturely

Lead Sponsor

Trials

2

Recruited

500+

Published Research Related to This Trial

Over half (50.8%) of the 1616 surveyed women rated their postnatal hospital care as 'very good', but many reported negative experiences related to caregiver interactions, such as midwives being perceived as rushed and not always sensitive.

The study highlights that communication and support regarding baby feeding and post-discharge advice significantly impact women's satisfaction with postnatal care, suggesting a need for improved caregiver training and staffing in postnatal wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's views and experiences of postnatal hospital care in the Victorian Survey of Recent Mothers 2000. Brown, SJ., Davey, MA., Bruinsma, FJ.[2022]

Low-income, urban, first-time mothers generally feel confident in their ability to care for themselves and their infants during the first six months postpartum, with few reported unmet learning needs.

External stressors such as financial issues and unstable living conditions significantly impact the health outcomes of these mothers, highlighting the need for healthcare providers to connect them with additional community resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-income, urban minority women's perceptions of self- and infant care during the postpartum period. Suplee, PD., Gardner, MR., Borucki, LC.[2016]

The study compared the physiological responses of caregivers using traditional baby slings and modern front-worn harness carriers, involving 20 participants carrying baby dummies weighing 7 and 10 kg.

Results showed minimal differences in muscle activity and shoulder pressure between the two carrier types, but significant variations were noted based on the weight of the dummies, suggesting that carrier design could be improved for better comfort and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baby carriers: a comparison of traditional sling and front-worn, rear-facing harness carriers. Wu, CY., Huang, HR., Wang, MJ.[2017]

Caregivers of NICU graduates reported that using baby carriers for kangaroo care significantly reduced their stress and anxiety levels, promoting a sense of calm and improved attachment with their infants.

The study suggests that babywearing can serve as an effective intervention to support caregivers' mental health and well-being, potentially mitigating issues like depression and posttraumatic stress disorder after NICU discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Experience of Babywearing a NICU Graduate? Miller, RR., Bedwell, S., Laubach, LL., et al.[2022]

A report of 19 cases of sudden unexpected death in infancy (SUDI) linked to soft infant carriers highlights that these carriers can pose a significant risk of suffocation, particularly in healthy full-term babies under 3 months old.

The findings suggest that infant carriers are an underestimated cause of suffocation-related deaths in neonates, emphasizing the need for increased awareness and safety measures when using these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden deaths in adult-worn baby carriers: 19 cases. Bergounioux, J., Madre, C., Crucis-Armengaud, A., et al.[2022]

Women perceive postnatal care as having low value for healthy mothers and infants, which contributes to low uptake of these services, highlighting a significant gap in care.

There is a strong desire among women for more emotional and psychosocial support during the postnatal period, indicating that current care models may not adequately address the holistic needs of new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence uptake of routine postnatal care: Findings on women's perspectives from a qualitative evidence synthesis. Sacks, E., Finlayson, K., Brizuela, V., et al.[2023]

The first 6 weeks postpartum, often called the fourth trimester, are crucial for the health of both mothers and newborns, yet many new mothers miss important follow-up appointments that could prevent serious health issues.

To improve postpartum care during the COVID-19 pandemic, a mobile clinic was launched in Boston, providing comprehensive care with an average of 3 visits for each mother and newborn, addressing barriers to care and promoting better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. McGuinness, C., Mottl-Santiago, J., Nass, M., et al.[2023]

Despite campaigns to reduce sudden unexpected infant death, caregivers still place infants in unsafe sleeping environments like car seats and slings, which can lead to suffocation and breathing problems.

Healthcare providers must educate parents and caregivers about the dangers of using sitting devices for sleep and model safe practices to ensure infant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Risks Sitting and Carrying Devices Pose to Safe Infant Sleep. Rholdon, R.[2017]

A study involving 36 newborns (24 preterm and 12 term) found that carrying infants in slings does not lead to clinically significant changes in oxygen saturation or heart rate, indicating safety in this practice.

While there was a slight decrease in oxygen saturation when infants were carried in slings compared to lying in a pram, these changes were not clinically relevant, and any episodes of desaturation or bradycardia were only observed in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory stability of premature and term infants carried in infant slings. Stening, W., Nitsch, P., Wassmer, G., et al.[2019]

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